Job Description:

1. Responsible to ensure the new vendor development sampling of Raw materials and Packing materials.

2. Responsible to ensure analysis of new vendor development Raw Materials Packing materials.

3. Analysis of formulation development - finished Products and Stability samples.

4. Responsible to ensure preparation and storage of volumetric solutions, reagents and indicators (analytical dept).

5. Responsible to prepare and review of specifications and testing procedures for raw materials, packing materials, excipients, in-process, intermediates and finished products (R&D).

6. Responsible to review of Sample order certificate of analysis.

7. Responsible for to review of R&D stability data.

8. Responsible to attend ongoing training programmes and to train subordinates.

9. Responsible for investigation of deviations /OOS /OOT/Deviations/Complaints if any observed in the Analytical Department.

10 Responsible for authenticate of change controls related to Analytical Department.

11. Responsible to ensure reconciliation of laboratory chemicals.

12. Responsible to ensure calibration of laboratory instruments as per schedule.

13. Responsible to ensure completion of periodic qualification / validation of laboratory Equipment as per schedule.

14. Responsible to ensure stability samples management and handling of stability chambers.

15. Responsible to ensure analyst qualification /validation before allotting the respective sample

To the analyst for analysis.

16. Initiate for method development and validation of analytical methods – FP & new key raw materials if applicable under guidance of QC/ADL head.

17. Initiate for Cleaning method development and validation under guidance of QC/ADL head.

18. Implementation of Good Laboratory Practices (GLP) in the area.

KNOWLEDGE & SKILLS

HPLC, GC, UV and other equipment’s use in analytical dept

Good communication skills